Commission Directive 2008/16/EC of 15 February 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include etofenprox as an active substance in Annex I thereto (Text with EEA relevance)

• Published date: 16 February 2008
• Subject Matter: Internal market - Principles,Free movement of goods,Environment,Plant health legislation
• Official Gazette Publication: Official Journal of the European Union, L 42, 16 February 2008

16.2.2008 EN Official Journal of the European Union L 42/48

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COMMISSION DIRECTIVE 2008/16/EC

of 15 February 2008

amending Directive 98/8/EC of the European Parliament and of the Council to include etofenprox as an active substance in Annex I thereto

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,

Whereas:

(1) Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market and amending Regulation (EC) No 1896/2000 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes etofenprox.

(2) Pursuant to Regulation (EC) No 2032/2003, etofenprox has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC.

(3) Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 11 October 2005 in accordance with Article 10(5) and (7) of Regulation (EC) No 2032/2003.

(4) The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 21 June 2006, in an assessment report.

(5) The review of etofenprox did not reveal any open questions or concerns to be addressed by the Scientific Committee on Health and Environmental Risks.

(6) It appears from the examinations made that biocidal products used as wood preservatives and containing etofenprox may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. However, acceptable risks to human health were only identified for seasonal and intermittent (up to three months per year) use. It is therefore appropriate to include etofenprox in Annex I to Directive 98/8/EC, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing etofenprox can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. Authorisations for products to be used year-round will require the submission of dermal absorption data in order to demonstrate that the products can be used without unacceptable risks to human health.

(7) In the light of the findings of the assessment report, and in particular of the risk identified for workers, it is appropriate to require that products containing etofenprox and intended for industrial use as wood preservatives be used with appropriate protective equipment.

(8) Not all potential

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